Method and apparatus for anastomosis including annular joining member

ABSTRACT

Apparatus and methods for performing a surgical anastomotic procedure are disclosed herein. Apparatus according to the present disclosure include a tubular body having a distal end and a proximal end and defining a longitudinal axis, the tubular body including an expandable anchor provided near the distal end thereof and an expandable cuff provided near the distal end of the tubular body and proximal of the expandable anchor, and a joining member ( 200 ) configured and adapted to be received about the expandable cuff of the tubular body, the joining member having an annular body portion ( 202 ) including a pair of opposed terminal edges ( 204, 206 ). The joining member has a retracted position in which the pair of opposed terminal edges overlap by a predetermined amount and an expanded position in which the pair of opposed terminal edges overlap by an amount less than the predetermined amount.

BACKGROUND

1. Technical Field

The present disclosure relates to apparatus and methods for anastomosingtwo hollow body parts and, more particularly to apparatus and methodsfor anastomosing a urethral stump of a patient to the bladder followinga radical prostatectomy.

2. Background of Related Art

Anastomosis is the bringing together and/or joining of hollow or tubularstructures. Most body conduits are generally cylindrical inconfiguration and have a circular cross-section. When it is desired tosuture such a conduit, typically for attachment to another body conduit,sutures are placed around the circumference of the conduit in order tomaintain the patency of its lumen or channel. This type of attachment iscommonly referred to as an anastomosis. It can be appreciated that thesutures made on top of the conduit (i.e., on the side facing thesurgeon) in an anastomosis are made relatively more easily than thesutures made underneath the conduit (i.e., on the side facing away fromthe surgeon).

The complexity of anastomosis attachment is made manifestly apparent ina surgical procedure referred to generally as a radical prostatectomy(i.e., a well established surgical procedure for patients with localizedprostatic carcinoma). In general, radical prostatectomy proceduresrequire the removal of cancerous tissue while preserving sexual functionand continence in the patient. There are two primary types of radicalprostatectomy approaches for the removal of prostate cancer, theretropubic approach and the perineal approach.

In the retropubic approach, a long up-and-down incision is made in themidline of the abdomen from the navel to the pubic bone. After the lymphnodes have been removed for study by the pathologist and a determinationhas been made to proceed with the removal of the prostate gland, thespace underneath the pubic bone is cleaned and dissected and the removalof the entire prostate gland is generally begun at the end that isfarthest from the bladder, i.e., next to the external urethralsphincter. Next, the prostatic urethra is divided, the prostatic urethraand the prostate gland through which it goes are then pulled upwardstoward the bladder while the dissection continues behind the prostategland, separating it from the layer of tissue that is connected to therectum on its other side. As the dissection continues between theprostate and the rectum, the seminal vesicles, which are behind the baseof the bladder will be removed along with the prostate gland. Once theseminal vesicles are free, the entire prostate gland and the seminalvesicles are removed. The bladder neck is then stitched closed to asmall enough diameter so that it is about the same size as the stump ofthe urethra from which the prostate was detached. The bladder neck isthen pulled down into the pelvis and positioned against the urethralstump and stitched thereto. This stitching is done typically around aFoley catheter which has been inserted through the penis all the wayinto the bladder.

In the perineal approach, an inverted “U” shaped incision is made goingright over the anus, with the center of the “U” about three centimetersabove the margin of the anus. The prostate gland is then freed from itssurrounding structures by gentle dissection, and the urethra at the endof the prostate farthest from the bladder is isolated and divided. Thebladder neck is freed from the prostate, and, once the prostate glandhas been removed and the bladder neck has been closed sufficiently sothat the size of its opening approximates the size of the urethralopening, the urethra and the bladder neck are stitched together. Onceagain, a Foley catheter is left in place postoperatively for about twoweeks.

In each of the above described procedures, it is the attachment of theurethral stump to the bladder neck which is particularly difficult andcomplex. This difficulty is complicated by the tendency of the urethralstump to retract into adjacent tissue. As a result, considerable timeand effort must be expended to re-expose the urethral stump and beginthe re-anastomosis procedure. Further complicating this procedure is thefact that the urethral stump is hidden beneath the pubic bone thusrequiring that the surgeon work at a difficult angle and in positionsthat are uncomfortable and limiting.

Various devices have been proposed for facilitating this procedure. InU.S. Pat. No. 5,591,179, issued to Edelstein, there is disclosed asuturing device including a shaft with portions defining an interiorchannel extending between a proximal and a distal end of the shaft. Thischannel includes a generally axial lumen which extends to the proximalend of the shaft and a generally transverse lumen which extends from theaxial lumen distally outwardly to an exit hole at the outer surface ofthe shaft. A needle and suture can be back loaded into the transverselumen of the channel while a generally non-compressible member can bemovably mounted in the axial lumen of the channel. At the proximal endof the shaft a handle is provided with means operative to push themember distally through the lumen to deploy or expel the needle.

In U.S. Pat. No. 4,911,164, issued to Roth, there is disclosed a sutureguide with a curved distal portion. The distal portion of the sutureguide has a plurality of exterior axial grooves which can be used toalign and guide a curved needle and attached suture. In order to drivethe urethral stump to an accessible position, the device is providedwith a plurality of outwardly extendable members which engage the lumenof the urethra These members make it possible to push the urethral stumpinto approximation with the bladder neck.

In U.S. Pat. No. 5,047,039, issued to Avant et al., there is disclosed asurgical device for the ligation of a dorsal vein and subsequentanastomosis. This device contains a pair of enclosed needles each havingan attached suture which needles may be driven from the shaft of thedevice into adjacent tissue.

In general, none of the devices disclosed in the prior art referencesabove is simple to use or makes the anastomosis of the urethral stump tothe bladder neck easier. As such, each surgical procedure using priorart devices continues to be time consuming and requires great skill inorder to be performed. Accordingly, the need exists for radicalprostatectomy anastomosis devices which overcome the drawbacks of theprior art devices and which are quick and simple to use.

SUMMARY

Apparatus and methods for performing a surgical anastomotic procedureare disclosed herein. Apparatus according to the present disclosureinclude a tubular body having a distal end and a proximal end anddefining a longitudinal axis, the tubular body including an expandableanchor provided near the distal end thereof and an expandable cuffprovided near the distal end of the tubular body and proximal of theexpandable anchor, and a joining member configured and adapted to bereceived about the expandable cuff of the tubular body, the joiningmember having an annular body portion including a pair of opposedterminal edges. The joining member has a retracted position in which thepair of opposed terminal edges overlap by a predetermined amount and anexpanded position in which the pair of opposed terminal edges overlap byan amount less than the predetermined amount.

The expandable anchor has a first position in which the expandableanchor has a radius substantially equal to a radius of the tubular bodyand a second position in which the expandable anchor has a radius whichis larger than the radius of the tubular body. The expandable cuff has afirst position in which the expandable cuff has a radius substantiallyequal to a radius of the tubular body and a second position in which theexpandable cuff has a radius which is larger than the radius of thetubular body.

The joining member includes at least one annular array of openingsformed through the annular body portion. Each opening is preferablydefmed by a pair of opposed side walls transversely oriented withrespect to the longitudinal axis, a longitudinally oriented angledproximal wall and a longitudinally oriented angled distal wall, whereinthe proximal wall is angled such that an upper edge thereof is closer tothe at least one tab than a lower edge thereof. The distal wall isdesirably angled such that an upper edge thereof is closer to the atleast one tab than a lower edge thereof.

The joining member includes at least one tab extending from a first ofthe pair of terminal edges of the annular body portion. The at least onetab is configured and adapted to be received within an opening of the atleast one linear array of openings.

Preferably, each tab extends tangentially and distally from the first ofthe pair of terminal edges of the joining member and terminates in anangled terminal distal edge.

The joining member desirably includes a guide rail formed on an innersurface of the annular body portion along either side of the at leastone array of openings. The guide rails are desirably arranged toslidably receive the at least one tab therebetween.

The joining member desirably includes a distal terminal edge, a proximalterminal edge, and a guide channel formed near a second of the pair ofterminal edges of the annular body portion. The guide channel is defmedby a pair of side walls extending radially inward from the distal andproximal terminal edges of the annular body. The guide channel isdesirably further defined by an end wall interconnecting the terminalends of the pair of side walls.

The joining member desirably includes a plurality of flanges extendingradially outward from at least one of the distal and proximal terminaledges thereof. The joining member may include a plurality of projectionsformed along an outer surface of the annular body portion.

The joining member is preferably fabricated from a bio-absorbablematerial, a bio-compatible material or a shape memory alloy.

The joining member desirably includes a unidirectional coupling pairincluding at least one opening formed near a first of the pair ofterminal edges and a plurality of projections formed along the outersurface of the annular body portion. The plurality of projections areconfigured and adapted to be received within the at least one opening toallow the joining member to go from the retracted position to theexpanded position.

The apparatus further desirably includes a holder tube having a distalend and a proximal end. The holder tube is configured and adapted to bereceived about the tubular body and the joining member when in theretracted position.

The expandable cuff of the tubular body is desirably configured andadapted to press against an inner surface of the annular body portion ofthe joining member in order to expand the joining member from theretracted position to the expanded position.

A method for performing a surgical anastomosis is provided including thesteps of providing an apparatus for performing an anastomotic procedure,the apparatus including a tubular body having a distal end and aproximal end, the tubular body including an expandable anchor providednear the distal end thereof and an expandable cuff provided near thedistal end of the tubular body and proximal of the expandable anchor,and a joining member configured and adapted to be received about theexpandable cuff of the tubular body, the joining member having anannular body portion including a pair of opposed terminal edge, whereinthe joining member has a retracted position in which the pair of opposedterminal edges overlap by a predetermined amount and an expandedposition in which the pair of opposed terminal edges overlap by anamount less than the predetermined amount.

The method further includes the steps of passing the apparatus through abody lumen and through an opening in a body vessel such that theexpandable anchor of the tubular body is positioned within the bodyvessel, expanding the expandable anchor of the tubular body such thatthe expandable anchor of the tubular body has a radius which is largerthan an opening of the body vessel, withdrawing the tubular body untilthe body vessel contacts a distal end of the body lumen, positioning thejoining member over the expandable cuff at a location which extendsbetween at least a portion of the body vessel and at least a portion ofthe body lumen, and expanding the expandable cuff of the tubular bodyagainst the inner surface of the joining member to expand the joiningmember against at least the portion of the body vessel and at least theportion of the body lumen to secure the joining member into position.The expandable anchor may be retracted, the expandable cuff may beretracted, and the tubular body may be withdrawn from the body vesseland body lumen.

It is contemplated that the surgical anastomosis is a radicalprostatectomy, wherein the body vessel is the bladder and the body lumenis the urethra. The method further includes the step of removing theprostrate gland from between the urethra and the bladder to define aurethral stump and a bladder neck.

A radially expandable joining member is provided including an annularbody portion defining a longitudinal axis, the annular body portionincluding a distal terminal edge, a proximal terminal edge and a firstand a second side terminal edge, wherein each of the first and thesecond side terminal edges is longitudinally oriented, at least oneannular array of openings formed in the annular body, and at least onelocking tab extending tangentially from the first side terminal edge,each locking tab being in registration with a respective array ofopenings formed in the annular body and receivable in the openings ofthe at least one annular array of openings, wherein the joining memberhas a first position wherein the annular body has a first diameter and asecond position wherein the annular body has a second diameter which islarger than the first diameter, wherein the at least one locking tabinhibits the annular body from returning to the first diameter, onceexpanded to the second diameter, by being received in an opening of theat least one array of openings.

The joining member includes two annular arrays of openings formed in theannular body and two tabs extending tangentially from the first sideedge, wherein the two tabs are configured and dimensioned to bereceived, one each, within a respective opening formed in the annularbody. The joining member further includes guide rails formed, one each,along each side of the two annular arrays of openings formed in theannular body.

The joining member further includes a guide channel formed near thesecond side terminal edge of the annular body. The guide channel isdefined by a pair of side walls extending radially inward from thedistal end proximal terminal edges of the annular body. The guidechannel is further defined by an end wall interconnecting the terminalends of the pair of side walls.

The joining member further includes a plurality of flanges extendingradially outward from at least one of the distal and proximal terminaledges thereof.

These and other features of the apparatus and method disclosed herein,will become apparent through reference to the following description ofembodiments, the accompanying drawings and the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the disclosureand, together with the general description given above and the detaileddescription of the embodiments given below, serve to explain theprinciples of the present disclosure.

FIG. 1 is a perspective view of an anastomotic radial joining member inaccordance with an embodiment of the present disclosure;

FIG. 2 is a perspective view of an anastomotic radial joining member inaccordance with another embodiment of the present disclosure;

FIG. 3 is a perspective view of an anastomotic radial joining member inaccordance with an alternative embodiment of the present disclosure;

FIG. 4 is an enlarged cross sectional view of a locking mechanism forany of the radial joining members shown in FIGS. 1-3;

FIG. 5 is a perspective view of an insertion apparatus for any of theradial joining members shown in FIGS. 1-3;

FIG. 6 is a partially broken away perspective view illustrating thepassage of the insertion apparatus through a body lumen and into ahollow body organ;

FIG. 7 is a cross-sectional side elevational view illustrating thepositioning of the insertion tool and radial joining member as well asthe expansion of a distal expansion member within the hollow body organ;

FIG. 8 is a cross-sectional side elevational view illustrating theapproximation of the hollow body organ to the body lumen;

FIG. 9 is a cross-sectional side elevational view illustrating theexpansion of a proximal expansion member within the radial joiningmember in order to anchor the radial joining member within the hollowbody organ and the body lumen;

FIG. 10 is a cross-sectional side elevational view illustrating theretraction of distal and proximal expansion members and the radialjoining member anchored in position between the hollow body organ andthe body lumen; and

FIG. 11 is a cross-sectional side elevational view illustrating thefinal anastomosed hollow body organ and body lumen with the radialjoining member anchored in position.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Preferred embodiments of the presently disclosed anastomosis apparatuswill now be described in detail with reference to the drawing figureswherein like reference numerals identify similar or identical elements.In the drawings and in the description which follows, the term“proximal”, as is traditional will refer to the end of the surgicaldevice or instrument of the present disclosure which is closest to theoperator, while the term “distal” will refer to the end of the device orinstrument which is furthest from the operator.

Referring now to FIGS. 1-5, an anastomosis apparatus, in accordance withthe principles of the present disclosure, is shown generally asreference numeral 100. Although apparatus 100 offers significantadvantages to a radical prostatectomy procedure, it will be understoodthat the device is applicable for use in any anastomotic procedure wherethe end of a conduit is to be sutured to a hollow body organ.

Referring initially to FIGS. 14, a radially expandable joining member,in accordance with the present disclosure, is shown generally asreference numeral 200. Joining member 200 includes an annular bodyportion 202 having a substantially “C” shaped configuration, a firstside terminal edge 204 and a second side terminal edge 206. It isenvisioned that joining member 200 has a width defined by a distalterminal edge 208 and a proximal terminal edge 210.

Joining member 200 includes a first and a second annular array ofopenings 212 extending through annular body portion 202. Preferably,each of the first and second arrays is spaced from one another andparallel to distal and proximal terminal edges 208, 210. Preferably,each opening 212 is defined by a pair of side walls 214, a distal wall216 and a proximal wall 218. More preferably, it is envisioned thatdistal wall 216 of each opening 212 is angled such that an upper edge ofeach distal wall 216 is closer to second side terminal edge 206 than alower edge of each distal wall 216. It is further envisioned thatproximal wall 218 of each opening 212 is closer to second side terminaledge 206 than an upper edge of each proximal wall 218. While a pair ofarrays of openings 212 has been disclosed, it is envisioned that asingle array or more than a pair of arrays of openings can be formed inannular body portion 202.

Joining member 200 further includes a pair of locking tabs 220 extendingdistally from second side terminal edge 206. In accordance with thepresent disclosure, each locking tab 220 is co-axially aligned with arespective array of openings 212. Preferably, each locking tab 220includes an outer surface 222 which extends tangentially in a distaldirection from the outer surface of annular body portion 202 from alocation spaced a distance from second side terminal edge 206 of annularbody portion 202. Each locking tab 220 further includes an angled innersurface 224 which extends from second side terminal edge 206 of annularbody portion 202 and is oriented toward outer surface 222 of locking tab220 in order to define a terminal edge 226 spaced a distance from secondside terminal edge 206 of annular body portion 202. In accordance withthe present disclosure, each locking tab 220 has a width which is lessthan a width of a respective opening 212. It is envisioned that joiningmember 200 is provided with a number of locking tabs 220 which are lessthan the number of arrays of openings 212.

It is contemplated that joining member 200 further includes a pluralityof guide rails 228 formed on the inner surface of annular body portion202 in order to define discrete channels therebetween. Preferably, aguide rail 228 is provided on either side of each array of openings 212such that locking tabs 220 are slidably received therebetween.

Joining member 200 has an initial retracted position in which lockingtabs 220 and second side terminal edge 206 overlap first side terminaledge 204, a predetermined selected amount, along an inner surface ofannular body portion 202 (not shown). In this manner, locking tabs 220overlie a respective array of openings 212 and are received betweenadjacent guide rails 228 formed on either side of opening 212. Joiningmember 200 has a subsequent expanded position in which locking tabs 220and second terminal edge 206 overlap first side terminal edge 204, anamount less than the predetermined selected amount (not shown).

According to the present disclosure, when going from the retractedposition to the expanded position, outer surface 222 of locking tabs 220slide across and over angled distal walls 216 defining openings 212 ofannular body portion 202. Accordingly, annular body portion 202 ispermitted to expand radially outward upon the application of outwardlyoriented radial forces applied to the inner surface thereof. Inaccordance with the present disclosure, locking tabs 220 in cooperationwith openings 212 prevent the return of annular body portion 202 fromthe expanded position to the retracted position. In particular, wheninwardly oriented radial forces are applied to the outer surface ofannular body portion 202, terminal edge 226 of each locking tab 220 isreceived in a respective opening 212 such that angled inner surface 224of locking tabs 220 slide along angled proximal wall 218 definingopenings 212. Accordingly, as locking tabs 220 slide into respectiveopenings 212, annular body portion 202 is stopped from retracting whensecond side terminal edge 206 contacts the inner surface of annular bodyportion 202.

As seen in FIG. 1, in accordance with an embodiment of the presentdisclosure, joining member 200 includes a guide channel 230 formed atfirst side terminal edge 204. Guide channel 230 is defined by a pair ofside walls 232, 234 integrally formed with and extending radially inwardfrom a respective distal and proximal terminal edge 208, 210 and an endwall 236 interconnecting side walls 232, 234. In accordance with thepresent disclosure, guide channel 230 is configured and adapted toreceive locking tabs 220 and second terminal edge 206 therewithin whenjoining member 200 is in the retracted position. It is envisioned thatside walls 232, 234 maintain second side terminal edge 206 aligned withfirst side terminal edge 204 and ensure that annular body portion 202expands squarely. It is further envisioned that end wall 236 definingguide channel 230 inhibits locking tabs 220 and second side terminaledge 206 from becoming radially spaced from first side terminal edge204.

As seen in FIG. 2, in accordance with an alternate embodiment of thepresent disclosure, joining member 200 further includes a plurality ofdiscrete flanges 240 integrally formed along the outer surface ofannular body portion 202. Preferably, flanges 240 are orthogonallyoriented and are provided along both distal and proximal terminal edges208, 210. In particular, flanges 240 preferably commence at first sideterminal edge 204 of annular body portion 202 and terminate at alocation spaced a distance from second side terminal edge 206. In thismanner, second side terminal edge 206 can be received within guidechannel 230 without interference from flanges 240.

As seen in FIG. 3, in accordance with yet another embodiment of thepresent disclosure, end wall 236 of guide channel 230 has been removed.Removal of end wall 236 from guide channel 230 of the embodiment ofjoining member 200 shown in FIG. 3 permits annular body portion 202 tobe more easily expanded as compared to the embodiments shown in FIGS. 1and 2.

In accordance with the present disclosure, it is contemplated thatjoining member 200 can be made from a medical grade material, such as,for example, stainless steel or titanium, however, it is preferred thatjoining member 200 is fabricated from a medical grade bio-absorbablematerial, such as, for example, polyglycolic acid (PGA) and/orpolylactic acid (PLA). Preferably, joining member 200 is fabricated froma bio-absorable material which ensures that joining member 200 maintainsits structural integrity for a predetermined period of time, such as,for example, approximately two weeks. It is further contemplated thatjoining member 200 can be fabricated from a shape memory alloy.Accordingly, joining member 200, fabricated from the shape memory alloy,would have an initial retracted configuration prior toimplantation/insertion into position and an expanded configurationfollowing implantation/insertion into position.

Turning now to FIG. 4, it is envisioned that any of joining members 200shown in FIGS. 1-3 can be provided with a unidirectional barbed surfcoupling pair 250. In particular, as seen in FIG. 4, coupling pair 250includes at least one aperture 252 formed near first side terminal edge204 of annular body portion 202 and a plurality of projections 254formed along the outer surface annular body portion 202 near second sideterminal edge 206. Each of the plurality of projections 254 isconfigured and adapted to be received and cooperate with aperture 252.In accordance with the present disclosure, each projection 254 includesa ramped distal surface 256 and an orthogonal proximal surface 258.Accordingly, provided second side terminal edge 206 of annular bodyportion 202 is in close proximity with the inner surface of annular bodyportion 202, joining member 200 is permitted to expanded by a cammingeffect created by ramped distal surface 256 of projections 254 againstthe distal surfaces of aperture 252 and restricted from retracting by astopping effect created by orthogonal surface 258 of projections 254against the proximal surfaces of aperture 252.

As seen in FIG. 4, the outer surface of annular body portion 202 ofjoining member 200 can be provided with a plurality of projections 260extending therefrom. Preferably, projections 260 are spikes, however, itis envisioned that projections 260 can be transverse ribs, cones,pyramids, helical threads and the like.

Turning now to FIG. 5, an insertion tool for inserting joining member200, in accordance with the principles of the present disclosure, isshown generally as reference numeral 300. Insertion tool 300 includes atubular body 302, a holder tube 304 slidably received about tubular body302 and a sleeve 306 slidably received about holder tube 304.

Tubular body 302 has a distal end 308, a proximal end (not shown) anddefines a central lumen 310 therethrough. Tubular body 302 includes anexpandable anchor 312 provided near distal end 308 of tubular body 302and an expandable cuff 314 provided near distal end 308 of tubular body302 and proximally of expandable anchor 312.

In a preferred embodiment, tubular body 302 includes a firstinflation/deflation lumen (not shown) extending along the inner surfaceof central lumen 310 and is in fluid communication with expandableanchor 312 through at least one access opening formed in tubular body302. Expandable anchor 312 has a first position in which expandableanchor 312 has a radius substantially equal to a radius of tubular body302 and a second position in which expandable anchor 312 has a radiusgreater than the radius of tubular body 302. In use, the expandableanchor lumen is in fluid communication with a source of inflation fluidin order to inflate expandable anchor 312 from the first position to thesecond position.

In the preferred embodiment, tubular body 302 further includes a secondinflation/deflation lumen (not shown) extending along the inner surfaceof central lumen 310 and is in fluid communication with expandable cuff314 through at least one access opening formed in tubular body 302.Expandable cuff 314 has a first position in which expandable cuff 314has a radius substantially equal to a radius of tubular body 302 and asecond position in which expandable cuff 314 has a radius greater thanthe radius of tubular body 302. In use, the expandable cuff lumen is influid communication with a source of inflation fluid in order to inflateexpandable cuff 314 from the first position to the second position.

Holder tube 304 has a distal end 320, a proximal end (not shown) and anaxial lumen (not shown) extending therethrough. Axial lumen of holdertube 304 is dimensioned and sized to receive tubular body 302 therein.In accordance with the present disclosure, distal end 320 of holder tube304 is configure and adapted to retain a joining member 200 thereon.

Sleeve 306 has a distal end 330, a proximal end (not shown) and an axiallumen (not shown) extending therethrough. Axial lumen of sleeve 306 isdimensioned and sized to receive holder tube 304 therein.

Preferably, expandable anchor 312 and expandable cuff 314 are fabricatedfrom a medical grade polymer having suitable flexibility and structuralintegrity to withstand the forces associated with the inflation ofanchor 312 and cuff 314 and with the function of withdrawing the hollowbody organ and expanding joining member 200. While a fluid expandableanchor and cuff are described herein, it is envisioned that amechanically expandable anchor and cuff can be provided, such as, forexample, an onion sleeve or a double onion sleeve.

A preferred method of use and operation of anastomosis apparatus 100 ina radical anastomotic procedure will now be described in greater detailwith reference to FIGS. 1-11 and in particular with reference to FIGS.6-11. Apparatus 100 can be used in either the retropubic or the perinealprostatectomy approaches. With the prostate removed, the bladder neck“N” of the bladder “B” is first reconstructed by everting the innermucosal lining of bladder “B” and suturing it down to the outer wall ofbladder “B” using known surgical techniques. Likewise, urethral stump“S” of urethra “U” is reconstructed by everting the inner mucosal liningof urethral stump “S” and suturing it down to the outer wall of urethra“U”, using known surgical techniques.

Preferably, with bladder neck “N” reconstructed, bladder neck “N” issized to properly accommodate and retain distal end 308 of tubular body302 within bladder “B” using a standard tennis racket type closure(i.e., the opening of the bladder neck constituting the head of thetennis racket and a radial incision extending from the bladder neckconstituting the handle portion of the tennis racket. Most preferably,bladder neck “N” is sized to be approximately 7-8 mm in diameter.

With bladder neck “N” reconstructed, apparatus 100, including tubularbody 302, joining member 200, holder tube 304 and sleeve 306, is passedtrans-urethrally through urethra “U” until distal end 308 of tubularbody 302 extends out of urethral stump “S” and into bladder “B” throughbladder neck “N”, as indicated by arrow “A” in FIG. 5. In particular,distal end 308 of tubular body 302 is preferably positioned such thatexpandable anchor 312 of tubular body 302 is positioned entirely withinbladder “B”.

With tubular body 302 positioned within bladder “B”, as seen in FIG.Sand 6, a fluid, i.e., air, carbon dioxide, saline or the like, isintroduced through the expandable anchor lumen into expandable anchor312 in order to thereby expand and inflate anchor 312. Inflation andexpansion of anchor 312 will prevent tubular body 302 from beingwithdrawn from bladder “B”.

With anchor 312 in an expanded condition, tubular body 302 is withdrawnin a direction “C”, opposite direction “A”, as seen in FIG. 7. Astubular body 302 is withdrawn in direction “C”, bladder “B” is alsomoved in direction “C” and approximated with urethral stump “S”. Oncebladder “B” has been approximated to urethral stump “S”, holder tube304, having a joining member 200 in the first retracted position andoperatively coupled to distal end 320 thereof, is advanced distallythrough sleeve 306 until joining member 200 is positioned overexpandable cuff 314. In accordance with the present disclosure, joiningmember 200 is positioned such that distal terminal edge 208 is withinbladder “B” while proximal terminal edge 210 extends proximally ofexpandable cuff 314 and within urethra “U”. Sleeve 306 is then withdrawnin a proximal direction.

As seen in FIG. 9, with sleeve 306 withdrawn, a fluid, i.e., air, carbondioxide, saline or the like, is introduced through expandable cuffinflation/deflation lumen into expandable cuff 314 to thereby expand andinflate cuff 314 into contact with the inner surface of joining member200. Inflation of expandable cuff 314 results in the radial expansion ofjoining member 200, from the first retracted position to the secondexpanded position, and in turn the pressing of the outer surface ofjoining member 200 against the inner surface of urethra “U” and intobladder neck “N”, thus anchoring bladder “B” to urethra “U”. As seen inFIG. 10, expandable anchor 302 and expandable cuff 314 are retractedand, as seen in FIG. 11, tubular body 302, holding tube 304 and sleeve306 are withdrawn from within bladder “B” and urethra “U”.

In accordance with the present disclosure, as bladder neck “N” andurethral stump “S” constrict in diameter about joining member 200, i.e.,applies a radially inward oriented constriction force about the outersurface of annular body portion 202, tabs 220 will enter into and engageopenings 212 formed in annular body portion 202 and lock joining member200 in the expanded position within bladder neck “N” and urethral stump“S”. As described in greater detail above, as annular body portion 202is constricted, locking tabs 220 slide into and engage respectiveopenings 212 formed in annular body portion 212 until second sideterminal edge 206 of annular body portion 202 contacts the guide rails228 formed along the inner surface of annular body portion 202.

Preferably, if a joining member 200 having flanges 240 is used in theanastomotic procedure, as seen in FIGS. 7-11, flanges 240 formed alongdistal terminal edge 208 are positioned within bladder neck “N” so thatafter expansion of joining member 200, flanges 240 contact the innersurface of bladder neck “N” and inhibit withdrawal of joining member 200therefrom. Further, if a joining member 200 having a plurality ofprojections 260, i.e., spikes, formed along the outer surface of theannular body wall 202 is used in the anastomotic procedure, as seen inFIGS. 7-11, the spikes will dig into the surface of bladder neck “N” andurethra “U” in order to inhibit separation of bladder neck “N” fromurethral stump “S”.

The expandable anchor for engaging a body vessel may comprise anyexpandable structure, including those disclosed in certain embodimentsof the following PCT Applications, all filed on an even date herewith:application entitled Method And Apparatus For Anastomosis Including AnAnchoring Sleeve, invented by Scott Manzo; Method And Apparatus ForAnastomosis Including An Anchor For Engaging A Body Vessel AndDeployable Sutures, invented by Scott Manzo; Method And Apparatus ForAnastomosis Including An Expandable Anchor, invented by Russell Heinrichand Scott Manzo; Method And Apparatus For Anastomosis Including AnnularJoining Member, invented by Scott Manzo; Method And Apparatus ForAnastomosis Including An Expandable Member, invented by Russell Heinrichand Scott Manzo; Method And Apparatus For Anastomosis Including AnAnchoring Sleeve, invented by Scott Manzo; the disclosures of which areall hereby incorporated by reference herein, in their entirety.

The joining member for joining body vessels may comprise any joiningmember, including those disclosed in certain embodiments of thefollowing PCI Applications, all filed on an even date herewith:application entitled Method And Apparatus For Anastomosis Including AnAnchoring Sleeve, invented by Scott Manzo; Method And Apparatus ForAnastomosis Including An Anchor For Engaging A Body Vessel AndDeployable Sutures, invented by Scott Manzo; Method And Apparatus ForAnastomosis Including An Anchor For Engaging A Body Vessel AndDeployable Sutures, invented by Scott Manzo; Method And Apparatus ForAnastomosis Including An Anchoring Sleeve, invented by Scott Manzo;Method And Apparatus For Anastomosis Including An Expandable Anchor,invented by Russell Heinrich and Scott Manzo; Method And Apparatus ForAnastomosis Including Annular Joining Member, invented by Scott Manzo;Method And Apparatus For Anastomosis Including An Expandable Member,invented by Russell Heinrich and Scott Manzo; Method And Apparatus ForAnastomosis Including An Anchoring Sleeve, invented by Scott Manzo; thedisclosures of which are all hereby incorporated by reference herein, intheir entirety.

The methods and apparatus disclosed herein may be used for approximatingand/or joining the urethra and bladder, intestinal portions of the body,blood vessels or any other body vessels.

Although the illustrative embodiments of the present disclosure havebeen described herein with reference to the accompanying drawings, it isto be understood that the disclosure is not limited to theseembodiments, and that various other changes and modifications may beaffected therein by one skilled in the art without departing from thescope or spirit of the disclosure. All such changes and modificationsare intended to be included within the scope of the appended claims.

1. An apparatus for performing a surgical anastomosis, comprising atubular body having a distal end and a proximal end and defining alongitudinal axis, the tubular body including an expandable anchorprovided near the distal end thereof and an expandable cuff providednear the distal end of the tubular body and proximal of the expandableanchor; and a joining member configured and adapted to be received aboutthe expandable cuff of the tubular body, the joining member having anannular body portion including a pair of opposed terminal edges, whereinthe joining member has a retracted position in which the pair of opposedterminal edges overlap by a predetermined amount and an expandedposition in which the pair of opposed terminal edges overlap by anamount less than the predetermined amount.
 2. The apparatus according toclaim 1, wherein the expandable anchor has a first position in which theexpandable anchor has a radius substantially equal to a radius of thetubular body and a second position in which the expandable anchor has aradius which is larger than the radius of the tubular body.
 3. Theapparatus according to claim 2, wherein the expandable cuff has a firstposition in which the expandable cuff has a radius substantially equalto a radius of the tubular body and a second position in which theexpandable cuff has a radius which is larger than the radius of thetubular body.
 4. The apparatus according to claim 3, wherein the joiningmember includes at least one annular array of openings formed throughthe annular body portion.
 5. The apparatus according to claim 4, whereinthe joining member includes at least one tab extending from a first ofthe pair of terminal edges of the annular body portion, wherein the atleast one tab is configured and adapted to be received within an openingof the at least one linear array of openings.
 6. The apparatus accordingto claim 5, wherein each opening is defmed by a pair of opposed sidewalls transversely oriented with respect to the longitudinal axis, alongitudinally oriented angled proximal wall and a longitudinallyoriented angled distal wall, wherein the proximal wall is angled suchthat an upper edge thereof is closer to the at least one tab than alower edge thereof and the distal wall is angled such that an upper edgethereof is closer to the at least one tab than a lower edge thereof. 7.The apparatus according to claim 6, wherein each tab extendstangentially and distally from the first of the pair of terminal edgesof the joining member and terminates in an angled terminal distal edge.8. The apparatus according to claim 7, wherein the joining memberincludes a guide rail formed on an inner surface of the annular bodyportion along either side of the at least one array of openings, whereinthe guide rails slidably receive the at least one tab therebetween. 9.The apparatus according to claim 8, wherein the joining member includesa distal and a proximal terminal edge.
 10. The apparatus according toclaim 9, wherein the joining member includes a guide channel formed neara second of the pair of terminal edges of the annular body portion. 11.The apparatus according to claim 10, wherein the guide channel is defmedby a pair of side walls extending radially inward from the distal andproximal terminal edges of the annular body.
 12. The apparatus accordingto claim 11, wherein the guide channel is further defined by an end wallinterconnecting the terminal ends of the pair of side walls.
 13. Theapparatus according to claim 11, wherein the joining member includes aplurality of flanges extending radially outward from at least one of thedistal and proximal terminal edges thereof.
 14. The apparatus accordingto claim 11, wherein the joining member includes a plurality ofprojections formed along an outer surface of the annular body portion.15. The apparatus according to claim 11, wherein the expandable cuff ofthe tubular body is configured and adapted to press against an innersurface of the annular body portion of the joining member in order toexpand the joining member from the retracted position to the expandedposition.
 16. The apparatus according to claim 1, wherein the joiningmember is fabricated from a bio-absorbable material.
 17. The apparatusaccording to claim 1, wherein the joining member is fabricated from ashape memory alloy.
 18. The apparatus according to claim 1, wherein thejoining member includes a unidirectional coupling pair including atleast one opening formed near a first of the pair of terminal edges anda plurality of projections formed along the outer surface of the annularbody portion, each of the plurality of projections being configured andadapted to be received within the at least one opening to allow thejoining member to go from the retracted position to the expandedposition.
 19. The apparatus according to claim 1, further comprising aholder tube having a distal end and a proximal end, the holder tubebeing configured and dimensioned to be received about the tubular bodyand the joining member when in the retracted position.
 20. A method forperforming a surgical anastomosis, comprising the steps of: providing anapparatus for performing an anastomotic procedure, the apparatuscomprising: a tubular body having a distal end and a proximal end, thetubular body including an expandable anchor provided near the distal endthereof and an expandable cuff provided near the distal end of thetubular body and proximal of the expandable anchor; and a joining memberconfigured and adapted to be received about the expandable cuff of thetubular body, the joining member having an annular body portionincluding a pair of opposed terminal edge, wherein the joining memberhas a retracted position in which the pair of opposed terminal edgesoverlap by a predetermined amount and an expanded position in which thepair of opposed terminal edges overlap by an amount less than thepredetermined amount; passing the apparatus through a body lumen andthrough an opening in a body vessel such that the expandable anchor ofthe tubular body is positioned within the body vessel; expanding theexpandable anchor of the tubular body such that the expandable anchor ofthe tubular body has a radius which is larger than an opening of thebody vessel; withdrawing the tubular body until the body vessel contactsa distal end of the body lumen; positioning the joining member over theexpandable cuff at a location which extends between at least a portionof the body vessel and at least a portion of the body lumen; andexpanding the expandable cuff of the tubular body against the innersurface of the joining member to expand the joining member against atleast the portion of the body vessel and at least the portion of thebody lumen to secure the joining member into position.
 21. The methodaccording to claim 20, further comprising the step of retracting theexpandable anchor and the expandable cuff.
 22. The method according toclaim 21, further comprising the step of withdrawing the tubular bodyfrom the body vessel and the body lumen.
 23. The method according toclaim 20, wherein the surgical anastomosis is a radical prostatectomy.24. The method according to claim 23, wherein the body vessel is thebladder and the body lumen is the urethra.
 25. The method according toclaim 24, including the step of removing the prostrate gland frombetween the urethra and the bladder to define a urethral stump and abladder neck.
 26. A radially expandable joining member, comprising: anannular body portion defining a longitudinal axis, the annular bodyportion including a distal terminal edge, a proximal terminal edge and afirst and a second side terminal edge, wherein each of the first and thesecond side terminal edges is longitudinally oriented; at least oneannular array of openings formed in the annular body; and at least onelocking tab extending tangentially from the first side terminal edge,each locking tab being in registration with a respective array ofopenings formed in the annular body and receivable in the openings ofthe at least one annular array of openings, wherein the joining memberhas a first position wherein the annular body has a first diameter and asecond position wherein the annular body has a second diameter which islarger than the first diameter, wherein the at least one locking tabinhibits the annular body from returning to the first diameter, onceexpanded to the second diameter, by being received in an opening of theat least one array of openings.
 27. The joining member according toclaim 26, including two annular arrays of openings formed in the annularbody and two tabs extending tangentially from the first side edge,wherein the two tabs are configured and dimensioned to be received, oneeach, within a respective opening formed in the annular body.
 28. Thejoining member according to claim 27, further including guide railsformed, one each, along each side of the two annular arrays of openingsformed in the annular body.
 29. The joining member according to claim28, further including a guide channel formed near the second sideterminal edge of the annular body.
 30. The joining member according toclaim 29, wherein the guide channel is defined by a pair of side wallsextending radially inward from the distal end proximal terminal edges ofthe annular body.
 31. The joining member according to claim 30, whereinthe guide channel is further defined by an end wall interconnecting theterminal ends of the pair of side walls.
 32. The joining memberaccording to claim 31, further including a plurality of flangesextending radially outward from at least one of the distal and proximalterminal edges thereof.